antibiotic application

antibiotic application
SPL v7
SPL
SPL Set ID da436c35-a98f-4df7-9d23-885564734cef
Route
topical
Published
Effective Date 2016-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (400 [iU]) neomycin (3.5 mg) polymyxin b (5000 [iU])
Inactive Ingredients
mineral oil petrolatum water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-08-06

Purpose

First aid antibiotic

Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units)


Medication Information

Warnings

For external use only.

Purpose

First aid antibiotic

Directions

• Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage.

Other Information

Store at room temperature

Inactive Ingredients

Mineral oil, petrolatum, purified water

Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Use
  • First aid to help prevent infection in minor cuts, scrapes, and burns.
Do Not Use

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Package Labeling:

Stop Use and Ask A Doctor If

• the condition persists or gets worse • a rash or other allergic reaction develops.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Ask A Doctor Before Use If You Have

• deep or punture wounds • animal bites • serious burns.


Structured Label Content

Warnings

For external use only.

Purpose

First aid antibiotic

Directions

• Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage.

Other Information (Other information)

Store at room temperature

Inactive Ingredients (Inactive ingredients)

Mineral oil, petrolatum, purified water

Use
  • First aid to help prevent infection in minor cuts, scrapes, and burns.
Do Not Use (Do not use)

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Package Labeling:

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• the condition persists or gets worse • a rash or other allergic reaction develops.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• deep or punture wounds • animal bites • serious burns.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)